Kliniska studier

The 5 years follow-up study show that CoreTherm procedure combines the effectiveness of the “gold standard” (TURP) surgical procedure with fewer side effects

Surgical candidate with moderate to severe symptoms of BPH and LUTS to avoid complex surgery is supported by strong clinical level I evidence in a prospective randomized multicenter study with 5 years follow-up, published in Urology 2007.

CoreTherm Treatment vs TURP for clinical BPH

A prospective randomized multicenter study with 5 years Follow-up

CoreTherm IPSS CoreTherm TURP

  • Conciderable improvements over 5 years.
  • No significant different between CoreTherm and TURP.

IPSS = International Prostate Symptom Score, standardized measurement of subjective problems.

SAE’s 0-60 months after treatment

sae_diagram-3

High risk patients with no other option then lifelong catheterization

The high-risk patients with no other option than lifelong catheterization is supported by level I evidence in a prospective randomized controlled multicenter study published in Urology 2006. The result confirmed earlier studies: 79% of the patients receiving CoreTherm were relieved of their indwelling catheter vs 88% in the surgery group. CoreTherm again confirmed its favorable safety profile: one serious adverse event occurred in the CoreTherm group (hematuria) compared with five cases in the surgery group (hematuria, urinary tract infection, hemorrhage, stroke and bladder neck sclerosis). The study concluded that Coretherm can replace surgery as a treatment option for BPH-patients with huge prostate enlargement  (>100g) and presistent urinary retention and showed to be a valuable treatment option for high risk patients.

CoreTherm Treatment vs TURP / prostate enucleation surgery in patients with BPH and persistent urinary retention;

Conclution

  • CoreTherm can replace surgery as a treatment option for BPH-patients with large prostate enlargement (>100g) and persistent urinary retention.
  • Valuable treatment option for high risk patients with no other option than lifelong catheterization.
Patient unsuitable for surgery and subject to catheterization

Patients unsuitable for surgery and subject to catheterization is supported by an important paper from 2014; CoreTherm treatment of chronic urinary retention in patients unsuitable for surgery published in the Scandinavian Journal of Urology in 2014. In all, 124 patients were treated with CoreTherm: 77% were relieved of their indwelling catheters, which is consistent with previous results. The authors conclude that CoreTherm is an effective treatment for patients who are not candidates for surgery.**

Table 3 Patient and treatment data

CoreTherm treatment of chronic urinary retention in patients unsuitable for surgery
  • CoreTherm is an effective treatment for an elderly, fragile patient group unsuitable for surgery and with chronic urinary retention.
  • 77 % of patients was relieved of their catheter.
  • 79 % reported an improvement in their OoL

Median age: 80 years (61-92)
Median Prostate Volume: 60 g (31-300)